InspireMD Inc.

Greetings. Welcome to InspireMD third quarter 2021 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to David Holmes with LifeSci Advisors. Thank you. You may begin.

Thank you, Shari, and good morning, everyone. Thank you for joining us for the InspireMD third quarter 2021 financial results and corporate update conference call. Joining us today from InspireMD are Marvin Flossman, Chief Executive Officer, and Craig Shore, Chief Financial Officer. During this call, management will be making forward-looking statements, including statements that address InspireMD's expectations for future performance and operational results, particularly in light of the COVID-19 pandemic. Forward-looking statements involve risks and other factors that may cause actual results to differ materially from those statements. For more information about these risks, please refer to the risk factors described in InspireMD's most recently filed periodic reports on Form 10-K and Form 10-Q filed with the U.S. Securities and Exchange Commission and InspireMD's press release that accompanies this call, particularly the cautionary statements made in it. This call contains time-sensitive information that is accurate only as of today, November 9th, 2021. Except as required by law, InspireMD disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call. It is now my pleasure to turn the call over to Marvin Sussman, Chief Executive Officer. Marvin, please go ahead.

Thank you, David. Good morning and thank you all for joining the third quarter 2021 call. Also joining me today is Craig Shore, our Chief Financial Officer. I'd like to begin with the reiteration of our mission at InspireMD, which is to establish Seaguard APS as the standard of care solution to change the way carotid artery disease is managed and strokes are prevented. The Seaguard carotid stent system enables this change through its unique design and proprietary Micronet mesh protection. which has yielded an unmatched and growing body of clinical evidence in real-world practice as well as ongoing clinical studies. We serve equally all physician specialists treating carotid artery disease with focus on the stent system and patient outcomes. We create greater awareness of the advantages of C-Guard as a first-line option to a broad physician base as well as advanced new delivery systems and accessory solutions We believe we can enable the conversion of this surgically-dominated $5 billion global total addressable market to a less invasive endovascular standard of care. The third quarter of 2021 proved meaningful in our quest to deliver on our growing body of evidence, further differentiating C-Guard from all other first-generation and dual-layered stents in the market, with the publication in JAK of a randomized trial comparing C-Guard EPS against Abbott's first-generation open-celled Acculink. with clear differentiation and a statistically significant reduction of approximately 80% in periprocedural cerebral embolization in favor of Seaguard. We'll further discuss the results in this breakthrough publication later. Additionally, we continue to build market demand for Seaguard while gaining traction in our company objectives of global expansion, commercial growth, and development of pipeline offerings. Commercial business grew for the quarter 24% year-over-year in C-Guard sales, and for the nine months year-to-date, increased 45% over the same period in 2020. During the quarter, we sold 1,709 devices, an increase of 21% as compared to the third quarter of 2020, with scheduled procedures to normalize levels in most of our serve markets. In France, we've received the anticipated reimbursement approval to combine with our previously announced clinical approval for Sea Guard from the French National Authority for Health and have subsequently launched Sea Guard into the French market with 18 cases completed in the first week post-approval. These key commercial inflection points of expansion into new markets have also accelerated our plans to advance our direct sales efforts in selective strategic locations to capture higher average sales price and enable greater control of the sales process to drive growth, as we have demonstrated previously in the United Kingdom and now France. Our strategy in Asia continues with talks in Japan amongst distributor partners interested in representing SeaGuard. As we noted previously and consistent with our agreement in China several months ago, we believe the Asian market offers an accelerated opportunity for SeaGuard as the existing standard of care for procedural intervention is predominantly endovascular focused and less surgically dominated. Additionally, with the advanced enrollment in our C-Guardians FDA trial and greater U.S. physician experience with C-Guard, we're planning to establish a U.S. base of business, including addition of commercial leadership and operational infrastructure. Speaking of the U.S. C-Guardians trial, we've completed over 10% of the enrollment to date, led by our global principal investigator, Dr. Chris Metzger, at Ballad Health System in Eastern Tennessee. As we launched the trial in the U.S. with the top carotid stenting leaders, we're encouraged by the growing foundation of awareness and credibility through the utilization of C-Guard with investigator experience, positioning us for a successful and accelerated post-approval commercial launch. In reference to the prior mentioned publication of the randomized trial comparing C-Guard to the Abbott-Ackling stent, trial compared C-Guard EPS against the first-generation Abbott Aculink in a CAS-related ipsilateral cerebral embolism study measured by DWMRI following CAS and found a dramatic 4.5-fold reduction in periprocedural cerebral embolism in favor of C-Guard. Most significantly, this reduction in procedural events was reflected in both volume and number of lesions in favor of C-Guard, consistent with the Micronet-covered prevention, delivering cerebral protection both during and following casts. The ability of our Micronet mesh to prevent the migration of thrombus in the lumen of the vessel following casts remains the foundational advantage of C-Guard against all other stent alternatives, and this important publication adds further evidence to the advantages of our stent platform. Although the study was not powered to show statistical significance of clinical outcomes, there were two observed ipsilateral strokes which occurred in the Abbott AccuLink arm, but no neurological events occurred with the C-Guard arm, further suggesting the value of post-procedural protection from the Micronet mesh. Our investment in our pipeline of innovation continues with new advanced tools to enable more CAS procedures. Our progress with the previous mentioned new delivery systems continues with anticipated approval in 2022, which we believe will facilitate greater accelerated growth in overall global market demand and will significantly address the conversion of surgical procedures to endovascular . To summarize, the quarter reflects our priority of execution and growth, which will continue to drive our objective of establishing C-Guard carotid stent system as the foundational enabler of endovascular convergence from open surgery. We chart a new course for how CAD is managed and stroke is prevented with our clinically proven C-Guard EPS system, demonstrating superior clinical outcomes for patients compared to alternative carotid stent types, conventional or next generation double layer stents, as well as invasive surgical procedures such as endarterectomy. We're encouraged by our progress and mission as we continue to invest in our future to leverage and unlock their tremendous potential to change the way carotid artery disease is managed and stroke is prevented. With that, I'll turn the call over to Craig, who will review the first quarter financials. Craig.